The effect of the Whole Body Vibration on the static and dynamic balance indices and Invertor and Evertor muscle torque in Functional Ankle Instability
The purpose of this double-blind clinical trial is to investigate the impact of the Whole body Vibration on the static and dynamic balance indices and the invertors and evertors muscle torque in the individuals with functional ankle instability. The patients with the functional ankle instability that the number of whom is determined by a pilot study and meet the inclusion criteria are enrolled in the experimental group and the control group is selected from the individuals with no background of ankle sprain. The patients in the experimental group will be treated by the whole body vibration and the individuals in the control group will receive no treatment. First, the static and dynamic balance as well as the muscle torque in the healthy legs are compared with the legs with functional ankle instability to determine whether these indices in the individuals with the functional ankle instability suggest any differences with those of the individuals in the control group or not. The differences between the individuals in the experimental and control groups being registered, the clinical intervention for the experimental group will commence. The patients in the experimental group will receive clinical intervention and then they will be assessed in terms of the static and dynamic balance indices and invertor and evertor muscles torque.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011135112N2
Registration date:2011-11-22, 1390/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-22, 1390/09/01
Registrant information
Name
Rozita Hedayati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
hedayati@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Whole Body Vibration on the static and dynamic balance indices and Invertor and Evertor muscle torque in Functional Ankle Instability
Public title
The effect of the Whole Body Vibration on the balance and ankle muscle power in Functional Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 1 significant lateral (inversion) sprain of the right ankle, in which the subject was unable to bear weight or was placed on crutches, within the last year, No reported history of fracture to either ankle, At least 1 repeated injury or the perception of ankle instability or ‘‘giving way’’ in the right ankle, No formal or informal rehabilitation of the unstable ankle, No evidence of mechanical instability as assessed by an orthopedic physician using Anterior Drawer and Talar Tilt Tests
Exclusion criteria: Pain, Abnormal gait, Mechanical injury to the ligaments, Participants who had not experienced any lower extremity injury in the last 6 months, subjects who were not suffering from a lower extremity injury and had no history of major injury that resulted in severe ligamentous damage, fracture, need for surgery or therapeutic treatment, Visual disorders not to be improved by glasses, vestibular disorders, balance disorders, history of falling, use of drugs that affect postural control system
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan Rehabilitation University; Damghan Road, 5 km towards Damhan
City
Semnan
Postal code
Approval date
2010-10-26, 1389/08/04
Ethics committee reference number
111318/90
Health conditions studied
1
Description of health condition studied
Functional Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain and strain of ankle
Primary outcomes
1
Description
Dynamic and static balance
Timepoint
Before and after intervention
Method of measurement
Biodex
2
Description
Invertor and evertor muscles torque
Timepoint
Before and after intervention
Method of measurement
Isokinetic
Secondary outcomes
empty
Intervention groups
1
Description
Control: Control group gives no treatments in this time.
Category
N/A
2
Description
Intervention: Treatment with the Whole Body Vibration for 6 weeks and 3 times a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Treatment Centers and Clinics affiliated to the Semnan University of Medical Science
Full name of responsible person
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Semnan Rehabilitation University; Damghan Road, 5 km towards Damhan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rozita Hedayati
Position
PHD,Head of Physiotherapy Department
Other areas of specialty/work
Street address
Semnan Rehabilitation University; Damghan Road, 5 km towards Damhan
City
Semnan
Postal code
Phone
+98 23 1335 4180
Fax
Email
hedayati@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rozita Hedayati
Position
PHD, Head of Physiotherapy Department
Other areas of specialty/work
Street address
Semnan Rehabilitation University; Damghan Road, 5 km towards Damhan
City
Semnan
Postal code
Phone
+98 23 1335 4180
Fax
Email
hedayati@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rozita Hedayati
Position
PHD, Head of Physiotherapy Department
Other areas of specialty/work
Street address
Semnan Rehabilitation University; Damghan Road, 5 km towards Damhan
City
Postal code
Phone
+98 23 1335 4180
Fax
Email
hedayati@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)